Negative Pressure Wound Therapy in the Outpatient Setting Corporate Medical Policy

Transcription

1 Negative Pressure Wound Therapy in the Outpatient Setting Corporate Medical Policy File Name: Negative Pressure Wound Therapy in the Outpatient setting File Code: UM.DME.10 Origination: 12/15/2010 Last Review: 09/2018 Next Review: 09/2019 Effective Date: 01/01/2019 Description/Summary Negative pressure wound therapy (NPWT) consists of the use of a negative pressure or suction device to aspirate and remove fluids, debris and infectious materials from the wound bed to promote the formation of granulation tissue and wound healing. For definitions, please see Attachment II. Policy Coding Information Click the links below for attachments, coding tables & instructions. Attachment I- CPT & HCPCS Code List & Instructions Initiation of a Powered Negative Pressure Wound Therapy (NPWT) An initial therapeutic trial of up to 30 days using a powered negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors such diabetes, nutrition, relief of pressure, etc., may be considered medically necessary in the following indications: Chronic (>90 days) stage III or IV pressure ulcers that have failed to heal despite optimal wound care when there is high-volume drainage that interferes with healing and/or when standard dressings cannot be maintained due to anatomic factors, OR Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure AND there is exposed bone, cartilage, tendon, or foreign material within the wound OR Wounds in patients with underlying clinical conditions which are known to Page 1 of 13

2 negatively impact wound healing, which are non-healing (at least 30 days), despite optimal wound care. (Examples of underlying conditions include, but are not limited to diabetes, malnutrition, small vessel disease, and morbid obesity. Malnutrition, while a risk factor, must be addressed simultaneously with the negative pressure wound therapy. Continuation of Powered NPWT Continuation of the powered NPWT system, as part of a comprehensive wound care program, may be considered medically necessary following an initial therapeutic trial if the treatment trial has resulted in documented objective improvements in the wound, and if there is ongoing objective improvement during subsequent treatment. Objective improvements in the wound should include the development and presence of healthy granulation tissue, progressive wound contracture and decreasing depth, and/or the commencement of epithelial spread from the wound margins. When a service or procedure is considered not medically necessary Continuation of the powered NPWT system is considered not medically necessary when any of the following occurs: The therapeutic trial or subsequent treatment period has not resulted in documented objective improvement in the wound; OR The wound has developed evidence of wound complications contraindicating continued NPWT; OR The wound has healed to an extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments. Negative pressure wound therapy is contraindicated and not medically necessary in the presence of ANY of the following: The wound is a Stage I or Stage II pressure ulcer; OR necrotic tissue with eschar present; OR untreated osteomyelitis within the vicinity of the wound; OR presence of a fistula to an organ or body cavity within the cavity of the wound; OR malignancy in the wound; OR exposed vasculature; OR exposed nerves; OR exposed anastomotic site; OR exposed organs; OR active bleeding; OR Patient is non-adherent to plan of care. When a service is considered investigational Use of non-powered NPWT systems for the treatment of acute or chronic wounds is considered investigational. Page 2 of 13

3 Information required A written order for the NPWT and supplies, signed and dated by the treating physician who is responsible for managing the wound care. Incomplete authorization requests may result in a delay of decision pending submission of missing information. To be considered compete, requests for authorization of negative pressure wound therapy must include the following: The nutritional status of the patient; Medical history and management of all underlying conditions, or documentation to support use as an initial therapy, including but not limited to ANY ONE of the following conditions: - Diabetes; - Edema; - Venous insufficiency; - Arterial insufficiency; - Incontinence; - Dietary/ nutritional deficiency. Wound description at the time NPWTP is initiated, from a nurse or physician who is responsible for the wound dressing changes which includes ALL of the following: - Location of the wound; - Wound measurement including length, width and depth; - Description of the wound, including color, odor, etc. - Quantity and description of drainage; - Presence of granulation and necrotic tissue; - Debridement of necrotic tissue if present. Documentation of the existence of ANY ONE of the following ulcer types: - A stage III pressure ulcer (see description of stages); - A Stage IV pressure ulcer; - Neuropathic ulcers (i.e. diabetic); - Venous or arterial insufficiency ulcers unresponsive to standard therapy - where: o Compression bandages and/or garments have been consistently applied; and o Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities - A surgically created wound (i.e. dehiscence; dehisced wounds or wound with exposed hardware or bone; or post sternotomy wound infection or mediastinitis; complications of a surgically created wound where accelerated Page 3 of 13

4 granulation therapy is necessary and cannot be achieved by other available topical wound treatment.) - A traumatic wound (i.e. pre-operative flap or graft). References 1. Rhee SM, Valle MF, Wilson LM, et al. Negative Pressure Wound Therapy Technologies For Chronic Wound Care in the Home Setting. Evidence Report/Technology Assessment. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No I.) Rockville, MD: Agency for Healthcare Research and Quality. September 15, i d96ta.pdf. Accessed December 16, Rhee SM, Valle MF, Wilson LM, et al. Negative pressure wound therapy technologies for chronic wound care in the home setting: A systematic review. Wound Repair Regen. Jul 2015;23(4): PMID Sullivan N, Snyder DL, Tipton K, et al. Technology assessment: Negative pressure wound therapy devices. 2009; Accessed November, Samson D, Lefevre F, Aronson N. Wound-healing technologies: low-level laser and vacuum-assisted closure. Evidence Report/Technology Assessment No (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center, under Contract No ) AHRQ Publication No. 05-E Rockville, MD: Agency for Healthcare Research and Quality. Dec PMID Ubbink DT, Westerbos SJ, Evans D, et al. Topical negative pressure for treating chronic wounds. Cochrane Database Syst Rev. 2008(3):CD PMID Moues CM, Vos MC, van den Bemd GJ, et al. Bacterial load in relation to vacuum- assisted closure wound therapy: a prospective randomized trial. Wound Repair Regen. Jan-Feb 2004;12(1): PMID Braakenburg A, Obdeijn MC, Feitz R, et al. The clinical efficacy and cost effectiveness of the vacuum-assisted closure technique in the management of acute and chronic wounds: a randomized controlled trial. Plast Reconstr Surg. Aug 2006;118(2): ; discussion PMID Mody GN, Nirmal IA, Duraisamy S, et al. A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India. Ostomy Wound Manage. Dec 2008;54(12): PMID Dumville JC, Webster J, Evans D, et al. Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Syst Rev. 2015;5:CD PMID Wanner MB, Schwarzl F, Strub B, et al. Vacuum-assisted wound closure for cheaper and more comfortable healing of pressure sores: a prospective study. Scand J Plast Reconstr Surg Hand Surg. 2003;37(1): PMID Dumville JC, Hinchliffe RJ, Cullum N, et al. Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus. Cochrane Database Syst Rev. 2013;10:CD PMID Blume PA, Walters J, Payne W, et al. Comparison of negative pressure wound Page 4 of 13

5 therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care. Apr 2008;31(4): PMID Armstrong DG, Lavery LA. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. Nov ;366(9498): PMID Dalla Paola L, Carone A, Ricci S, et al. Use of vacuum assisted closure therapy in the treatment of diabetic foot wounds. Journal of Diabetic Foot Complications. J Diabetic Foot Complications. 2010;2: Dumville JC, Land L, Evans D, et al. Negative pressure wound therapy for treating leg ulcers. Cochrane Database Syst Rev. 2015;7:CD PMID Vuerstaek JD, Vainas T, Wuite J, et al. State-of-the-art treatment of chronic leg ulcers: A randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. J Vasc Surg. Nov 2006;44(5): ; discussion PMID Dumville JC, Munson C, Christie J. Negative pressure wound therapy for partialthickness burns. Cochrane Database Syst Rev. 2014;12:CD PMID Bloemen MC, van der Wal MB, Verhaegen PD, et al. Clinical effectiveness of dermal substitution in burns by topical negative pressure: a multicenter randomized controlled trial. Wound Repair Regen. Nov-De2012;20(6): PMID c 19. Runkel N, Krug E, Berg L, et al. Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus. Injury. Feb 2011;42 Suppl 1:S1-12. PMID Webster J, Scuffham P, Stankiewicz M, et al. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2014;10:CD PMID Dumville JC, Owens GL, Crosbie EJ, et al. Negative pressure wound therapy for treating surgical wounds healing by secondary intention. Cochrane Database Syst Rev. 2015;6:CD PMID Stannard JP, Volgas DA, McGwin G, 3rd, et al. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. Jan 2012;26(1): PMID Stannard JP, Robinson JT, Anderson ER, et al. Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma. J Trauma. Jun 2006;60(6): PMID Monsen C, Acosta S, Mani K, et al. A randomised study of NPWT closure versus alginate dressings in perivascular groin infections: quality of life, pain and cost. J Wound Care. Jun 2015;24(6):252, , PMID Masden D, Goldstein J, Endara M, et al. Negative pressure wound therapy for atrisk surgical closures in patients with multiple comorbidities: a prospective randomized controlled study. Ann Surg. Jun 2012;255(6): PMID Chio EG, Agrawal A. A randomized, prospective, controlled study of forearm donor site healing when using a vacuum dressing. Otolaryngol Head Neck Surg. Feb 2010;142(2): PMID Biter LU, Beck GM, Mannaerts GH, et al. The use of negative-pressure wound Page 5 of 13

6 therapy in pilonidal sinus disease: a randomized controlled trial comparing negative-pressure wound therapy versus standard open wound care after surgical excision. Dis Colon Rectum. Dec 2014;57(12): PMID Armstrong DG, Marston WA, Reyzelman AM, et al. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen. Mar-Apr 2011;19(2): PMID Armstrong DG, Marston WA, Reyzelman AM, et al. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair Regen. May-Jun 2012;20(3): PMID Marston WA, Armstrong DG, Reyzelman AM, et al. A Multicenter Randomized Controlled Trial Comparing Treatment of Venous Leg Ulcers Using Mechanically Versus Electrically Powered Negative Pressure Wound Therapy. Adv Wound Care (New Rochelle). Feb ;4(2): PMID Lerman B, Oldenbrook L, Eichstadt SL, et al. Evaluation of chronic wound treatment with the SNaP wound care system versus modern dressing protocols. Plast Reconstr Surg. Oct 2010;126(4): PMID Schwartz JA, Goss SG, Facchin F, et al. Single-use negative pressure wound therapy for the treatment of chronic lower leg wounds. J Wound Care. Feb 2015;24 Suppl 2:S4-9. PMID Grauhan O, Navasardyan A, Hofmann M, et al. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. May 2013;145(5): PMID Pauser J, Nordmeyer M, Biber R, et al. Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int Wound J. Aug PMID Vig S, Dowsett C, Berg L, et al. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus. J Tissue Viability. Dec 2011;20 Suppl 1:S1-18. PMID Hospenthal DR, Murray CK, Andersen RC, et al. Guidelines for the prevention of infections associated with combat-related injuries: 2011 update: endorsed by the Infectious Diseases Society of America and the Surgical Infection Society. J Trauma. Aug 2011;71(2 Suppl 2):S PMID Lipsky BA, Berendt AR, Cornia PB, et al. Infectious Diseases Society of America (IDSA), Clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clinical Infectious Disease2012;54(12): Accessed November, National Institute for Health and Clinical Excellence (NICE). Negative Pressure Wound Therapy for the Open Abdomen. IPG ;https// Accessed December 22, National Institute for Health and Care Excellence (NICE). NICE Clinical Guideline NG19. Diabetic Foot Problems: Prevention and Management. 2016; Accessed December 22, Page 6 of 13

7 Royal College of Nursing and National Institute for Health and Clinical Excellence. The Management of Pressure Ulcers in Primary and Secondary Care. Clinical Guidance ; Accessed November, American Society of Plastic Surgeons (ASPS). Evidence-based Clinical Practice Guideline: Chronic Wounds of the Lower Extremity. 2007; Guideline-Chronic-Wounds-of-the-Lower-Extremity.pdf. Accessed November, American College of Foot and Ankle Surgeons (ACFAS). Diabetic Foot Disorders: A Clinical Practice Guideline. 2006; Publications/Clinical-Consensus-Documents/Clinical-Consensus-Documents/. Accessed November, U.S. Food and Drug Administration. UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems: FDA Safety Communication February; Accessed January 2, De Vries FE, Wallert ED, Solomkin JS, et al. A systematic review and meta-analysis including GRADE qualification of the risk of surgical site infections after prophylactic negative pressure wound therapy compared with conventional dressings in clean and contaminated surgery. Medicine (Baltimore). Sep 2016;95(36):e4673. PMID Karlakki SL, Hamad AK, Whittall C, et al. Incisional negative pressure wound therapy dressings (inpwtd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res. Aug 2016;5(8): PMID Lipsky BA, Berendt AR, Cornia PB, et al Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. J Am Podiatr Med Assoc. Jan-Feb 2013;103(1):2-7. PMID National Institute for Health and Clinical Excellence (NICE). Pressure ulcers: prevention and managment [CG179]. 2014; Accessed December 22, Document Precedence Blue Cross and Blue Shield of Vermont (BCBSVT) Medical Policies are developed to provide clinical guidance and are based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. The applicable group/individual contract and member certificate language, or employer s benefit plan if an ASO group, determines benefits that are in effect at the time of service. Since medical practices and knowledge are constantly evolving, BCBSVT reserves the right to review and revise its medical policies periodically. To the extent that there may be any conflict between medical policy and contract/employer benefit Page 7 of 13

8 plan language, the member s contract/employer benefit plan language takes precedence. Audit Information BCBSVT reserves the right to conduct audits on any provider and/or facility to ensure compliance with the guidelines stated in the medical policy. If an audit identifies instances of non-compliance with this medical policy, BCBSVT reserves the right to recoup all non-compliant payments. Benefit Determination Guidance Administrative and Contractual Guidance Prior approval may be required and benefits are subject to all terms, limitations and conditions of the subscriber contract. NEHP/ABNE members may have different benefits for services listed in this policy. To confirm benefits, please contact the customer service department at the member s health plan. Federal Employee Program (FEP): Members may have different benefits that apply. For further information please contact FEP customer service or refer to the FEP Service Benefit Plan Brochure. It is important to verify the member s benefits prior to providing the service to determine if benefits are available or if there is a specific exclusion in the member s benefit. Coverage varies according to the member s group or individual contract. Not all groups are required to follow the Vermont legislative mandates. Member Contract language takes precedence over medical policy when there is a conflict. If the member receives benefits through an Administrative Services Only (ASO) group, benefits may vary or not apply. To verify benefit information, please refer to the member s employer benefit plan documents or contact the customer service department. Language in the employer benefit plan documents takes precedence over medical policy when there is a conflict. Policy Implementation/Update information 07/2011 New policy. 03/2014 ICD-10 remediation. RLJ. 02/2015 Adopted some language from BCBSA policy# HCPCS codes added. New 2015 CPT codes added. 05/2016 Updated some language from BCBSA policy # Removed and Re-ordered some references. Diagnosis specificity removed. PA still required. Page 8 of 13

9 4/2017 Added updated references, minor bolding of headers. No change in policy statements. 09/2017 Reviewed policy no changes to policy statements. Updated references, added HCPCS code A7001 to coding table. Eligible Providers Qualified healthcare professionals practicing within the scope of their license(s). Approved by Medical Policy Committee Date Approved Joshua Plavin, MD, MPH Chief Medical Officer Attachment I CPT and HCPCS Code List & Instructions Code Type Number Description Policy Instructions The following codes will be considered medically necessary when applicable criteria have been met. CPT Negative pressure wound therapy (e.g., vacuum assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters No Prior Approval Required CPT Negative pressure wound therapy (e.g., vacuum assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters No Prior Approval Required Page 9 of 13

10 CPT Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters No Prior Approval Required CPT HCPCS A6550 Negative pressure wound therapy, (eg, vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories HCPCS A7000 Canister, disposable, used with suction pump, each HCPCS A7001 Canister, non-disposable, used with suction pump, each No Prior Approval Required $ (including rentals) $ (including rentals) $ (including rentals) HCPCS E2402 Negative pressure wound therapy electrical pump, stationary or portable $ (including rentals) Page 10 of 13

11 HCPCS K0743 Suction pump, home model, portable, for use on wounds $ (including rentals) HCPCS K0744 Absorptive wound dressing for use with suction pump, home model, portable, pad size 16 square inches or less $ (including rentals) HCPCS K0745 Absorptive wound dressing for use with suction pump, home model, portable, pad size more than 16 square inches but less than or equal to 48 square inches $ (including rentals) HCPCS K0746 Absorptive wound dressing for use with suction pump, home model, portable, pad size greater than 48 square inches $ (including rentals) Attachment II Definitions Dehisced wounds: a condition where a wound has a premature opening or splitting along natural or surgical suture lines due to improper healing Eschar: a dry scab that forms on skin that has been burned or exposed to corrosive agents Group 2 or 3 support surfaces: Two groups within the three classifications of specialized pressure reducing bed types available as a preventive measure for bedsores. The classification system is as follows: Group 1 - Pressure reducing mattress overlays; these overlays may be filled with air, water, foam or gel and are intended for placement over a standard mattress Group 2 - Special mattresses alone or fully integrated into a bed; these mattresses may be filled with air, water, foam or gel and are intended as a replacement for a standard mattress Page 11 of 13

12 Group 3 - Air Fluidized Beds; these are devices that employ the circulation of filtered air through silicone coated ceramic beads that create the characteristics of fluid, creating a sensation of floating Mediastinitis: a condition characterized by inflammation of the cavity that holds the heart and other organs Neuropathic ulcer: an ulcer resulting from the loss of sensation (i.e., pain, touch, stretch) as well as protective reflexes, due to loss of nerve supply to a body part Post-sternotomy: the period of time immediately following any surgery where the sternum or breastbone is opened to gain access to the chest cavity Pressure ulcer (National Pressure Ulcer Advisory Panel, 2007): A pressure ulcer is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction; a number of contributing or confounding factors are also associated with pressure ulcers; the significance of these factors is yet to be elucidated. Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined; stable (dry, adherent, intact without erythema or fluctuance) eschar on the heels serves as "the body's natural (biological) cover" and should not be removed Vacuum assisted wound therapy: a type of medical therapy that involves the use of suction (negative pressure) underneath airtight wound dressings to promote the healing of open wounds that have resisted previous treatments Pressure ulcer staging Suspected deep tissue injury Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear; the area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue. Note: Deep tissue injury may be difficult to detect in individuals with dark skin tones; evolution may include a thin blister over a dark wound bed; the wound may further evolve and become covered by thin eschar; evolution may be rapid exposing additional layers of tissue even with optimal treatment. The following staging criteria are based on the National Pressure Ulcer Advisory Panel (NPAUP) staging system. Stage I Non-blanchable redness of intact skin light toned skin, or darker or violet hue in darkly pigmented skin. Note: The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue; stage I may be difficult to detect in individuals with dark skin tones; may indicate "at risk" persons (a heralding sign of risk) Stage II Partial thickness loss of involving epidermis and/or dermis. Note: Presents as a shiny or dry shallow ulcer without slough or bruising;* this stage should not be used to Page 12 of 13

13 describe skin tears, tape burns, perineal dermatitis, maceration or excoriation *Bruising indicates suspected deep tissue injury Stage III Full thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Note: The depth of a stage III pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and stage III ulcers can be shallow; in contrast, areas of significant adiposity can develop extremely deep stage III pressure ulcers; bone/tendon is not visible or directly palpable. Stage IV Full thickness tissue loss with extensive destruction, tissue necrosis or damage to bone, muscle, or supporting structures. Note: The depth of a stage IV pressure ulcer varies by anatomical location; the bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and these ulcers can be shallow; stage IV ulcers can extend into muscle and/or supporting structures (e.g., fascia, tendon or joint capsule) making osteomyelitis possible; exposed bone/tendon is visible or directly palpable Unstageable Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Page 13 of 13